CONTEXT: This is why we love RWR. To see a treatment option being approved by the FDA off the back of RWD that had already been collected to improve the lives of kids recovering from extreme orthopaedic surgery is heart-warming. Proves the enormous value of the regulatory shift towards evaluation of RWE / RWD in product approvals.
IMPACT: High
READ TIME: 2 mins
Quality Level Mean [1 – 10]: 9
1. “For years, pediatric surgeon James Wall, MD, has observed his colleagues using a cold therapy device to significantly reduce post-operative pain in kids recovering from surgery to repair a sunken chest wall.”
2. “This is because getting devices approved for use in children typically requires a large clinical trial of pediatric patients, Wall said.”
3. “An approach to regulatory decision-making that uses information about how a medical device has performed in patients who are not in a clinical trial — known as real-world evidence — is making it easier to evaluate the safety and effectiveness of devices for pediatric patients.”
4. “The UCSF-Stanford Pediatric Device Consortium, which Wall co-directs on behalf of the Stanford Byers Center for Biodesign, is one of the first to use this approach.”
5. “Regulatory clearance is essential even though doctors are permitted to use devices “off label,” which is when a physician uses a device that the FDA hasn’t approved for treating a particular condition or patient population, Wall explained.”